Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca's supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been granted Priority Review by the FDA for treating previously untreated mantle cell lymphoma (MCL) in adults. This is based on the ECHO Phase III trial, which showed CALQUENCE combination reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy.

Key points:

• FDA decision expected in Q1 2025
• MCL is a rare, aggressive form of non-Hodgkin lymphoma
• CALQUENCE plus bendamustine and rituximab provided almost 1.5 years additional median progression-free survival
• Safety profile consistent with known data
• Application being reviewed under Project Orbis for potential international approval

Arcus Biosciences (NYSE:RCUS) has announced a clinical trial collaboration agreement with AstraZeneca to evaluate casdatifan (AB521), Arcus's investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC). This marks the second clinical collaboration between the two companies.

The study, sponsored and operationalized by AstraZeneca, aims to assess the safety and early efficacy of the combination therapy in advanced ccRCC patients. Arcus believes casdatifan has best-in-class potential based on observed PK and PD profiles and emerging clinical data from their ARC-20 study. The collaboration seeks to improve outcomes for ccRCC patients by combining HIF-2a inhibition with volrustomig.

Under the Gilead and Arcus collaboration agreement, Gilead retains the right to opt-in to development and commercialization for casdatifan after Arcus delivers a qualifying data package.

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for ENHERTU has been granted Priority Review in the US for treating HER2-low or HER2-ultralow metastatic breast cancer patients who have received at least one endocrine therapy. This is based on positive results from the DESTINY-Breast06 Phase III trial. The FDA action date is anticipated during Q1 2025.

ENHERTU also received Breakthrough Therapy Designation in this setting. The trial showed ENHERTU reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 13.2 months vs 8.1 months. Results were consistent in both HER2-low and HER2-ultralow expression patients.

If approved, ENHERTU would be the first HER2-directed therapy and antibody-drug conjugate for this patient population prior to chemotherapy for metastatic breast cancer.

ENHERTU, a HER2-directed antibody drug conjugate by Daiichi Sankyo and AstraZeneca, has been granted Priority Review in the U.S. for treating HER2 low or ultralow metastatic breast cancer patients who've received at least one endocrine therapy. This is based on the DESTINY-Breast06 phase 3 trial, which showed significant progression-free survival benefits. The FDA's decision date is set for February 1, 2025.

Key findings include:

• 37% reduced risk of disease progression or death
• 13.2 months median progression-free survival with ENHERTU vs 8.1 months with chemotherapy
• Consistent results in both HER2 low and ultralow expressions

If approved, ENHERTU would be the first HER2-directed therapy and antibody drug conjugate for these patients before chemotherapy in metastatic breast cancer treatment.

AstraZeneca's TAGRISSO® (osimertinib) has been approved in the US for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) whose disease has not progressed during or following platinum-based chemoradiation therapy. The approval is based on the LAURA Phase III trial results, which showed TAGRISSO reduced the risk of disease progression or death by 84% compared to placebo. Median progression-free survival was 39.1 months for TAGRISSO versus 5.6 months for placebo. The safety profile was consistent with previous findings. TAGRISSO is now approved for patients with EGFR mutations across all stages of NSCLC. The approval addresses a critical need for targeted therapy in this patient population.

Datopotamab deruxtecan (Dato-DXd), a TROP2 directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca, did not achieve statistical significance in final overall survival (OS) analysis in the TROPION-Breast01 phase 3 trial for patients with inoperable or metastatic HR positive, HER2 low or negative breast cancer. This follows previously reported positive progression-free survival (PFS) results.

Key points:

• The trial met its dual primary endpoint of PFS earlier
• Safety profile remained consistent with previous analysis
• Low rates of interstitial lung disease (ILD) were observed
• Subsequent treatments may have affected survival results

Despite the OS results, researchers noted the clinical value of datopotamab deruxtecan in this setting. The data will be presented at an upcoming medical meeting and shared with regulatory authorities.

FLUMIST, the only needle-free nasal spray flu vaccine in the US, has been approved for self-administration by adults up to 49 years old or caregiver administration for individuals 2-17 years old. This FDA approval, based on a usability study, makes FLUMIST the first self-administered influenza vaccine, allowing for at-home use.

The approval aims to increase vaccine accessibility and potentially boost vaccination rates, which have declined by 3.3% in US adults since 2020-21. FLUMIST Home will enable direct-to-home delivery for adults 18 and older through an online pharmacy system. The vaccine will also remain available in healthcare settings.

Seasonal influenza causes up to 1 billion infections annually, with 3-5 million severe cases. It impacts school attendance and work productivity, with 47% of school days and 1-2 workdays missed annually due to flu.

AstraZeneca's FASENRA (benralizumab) has been approved in the US for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis. The approval is based on the MANDARA Phase III trial, which showed:

- Nearly 60% of FASENRA-treated patients achieved remission
- 41% of patients fully tapered off oral corticosteroids
- FASENRA's efficacy was comparable to mepolizumab, the only other approved EGPA treatment

FASENRA is now the second biologic approved for EGPA in the US. It offers a convenient monthly subcutaneous injection and has shown potential to help patients taper off steroid therapy. This approval expands FASENRA's use beyond its existing indication for severe eosinophilic asthma.

AstraZeneca's IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated unprecedented 5-year overall survival in advanced liver cancer patients in the HIMALAYA Phase III trial. Key findings:

- 19.6% of patients treated with the STRIDE regimen were alive at 5 years vs 9.4% for sorafenib

- Risk of death reduced by 24% compared to sorafenib

- In patients achieving disease control, 28.7% treated with STRIDE were alive at 5 years vs 12.7% for sorafenib

- More patients on STRIDE experienced deep responses leading to longer survival

The safety profile was consistent with known profiles, with no new signals observed. This data reinforces the use of this novel dual immunotherapy regimen for advanced liver cancer patients.